Senior Manufacturing Automation Engineer
Location: Westbrook, ME
Contract: 12 Months
Schedule: Monday Friday, 8:00 AM 5:00 PM
Pay: 45-52/hr on W2 DOE
Job Summary
We are seeking a Senior Manufacturing Automation Engineer to support manufacturing processes, automation, equipment improvements, quality initiatives, and cost-saving projects within a cGMP/FDA/ISO-regulated environment.
Key Responsibilities- Lead manufacturing automation and equipment engineering projects.
- Specify, acquire, install, and implement manufacturing equipment.
- Troubleshoot machine logic, electromechanical systems, process controls, and drives.
- Lead equipment upgrades, continuous improvement, and process optimization.
- Perform Root Cause Analysis, FMEA, CAPA, and structured problem solving.
- Lead DOE, validation, testing, and data analysis activities.
- Develop and maintain SOPs, specifications, validation protocols, risk assessments, and technical documentation.
- Lead and mentor engineers and technicians.
- Manage cross-functional projects, timelines, and deliverables.
- Support process development, tooling, characterization, and validation.
- Ensure compliance with FDA, cGMP, ISO, safety, and quality requirements.
Required Qualifications- Bachelor s degree in Engineering or equivalent experience.
- 5+ years of engineering experience in a manufacturing environment.
- Experience with Lean Six Sigma/DMAIC or similar structured problem-solving methods.
- Strong experience with manufacturing automation, equipment troubleshooting, and process improvement.
- Experience with CAD and manufacturing system layouts.
- Knowledge of fabrication processes including CNC, machining, welding, and bolted connections.
Preferred Qualifications- Experience in FDA, cGMP, GMP, ISO, or ISO 13485 regulated environments.
- Medical device, pharmaceutical, diagnostics, or other regulated manufacturing experience.
- Experience with statistical analysis software, Excel, PowerPoint, and Power BI.
- Experience with validation, risk management, CAPA, and quality systems.
Interview: Microsoft Teams video interview